Abstract
Rozanolixizumab (rozanolixizumab-noli; RYSTIGGO®), a humanised immunoglobulin G4P monoclonal antibody, is a subcutaneously administered neonatal Fc receptor (FcRn) inhibitor approved for the treatment of both acetylcholine receptor (AChR) and muscle-specific kinase (MuSK) autoantibody-positive (Ab+) generalised myasthenia gravis (gMG) in adults. The pivotal, randomised, placebo-controlled phase III MycarinG trial demonstrated that a 6-week cycle of once-weekly rozanolixizumab ≈ 7 mg/kg or ≈ 10 mg/kg resulted in statistically significant and clinically meaningful improvements across all myasthenia gravis-specific scales assessed at day 43 versus placebo. Treatment benefits were rapid, sustained and consistent across repeated symptom-driven rozanolixizumab cycles. In a randomised, open-label, phase III crossover trial, self-administered rozanolixizumab improved MG symptoms regardless of whether manual push or infusion pump method was used. Rozanolixizumab was generally well tolerated with an acceptable safety profile; the most common adverse events were headache, diarrhoea, pyrexia and nausea. Thus, rozanolixizumab is an efficacious and generally well tolerated therapy for adults with AChR or MuSK Ab+ gMG, representing a convenient and valuable additional treatment option for these patients.